Outsourcing The shifting roles of CROs
The dial has been shifting for some time now on how much research and development work is carried out in-house by pharmaceutical companies. While outsourcing in the industry was once synonymous with manufacturing at scale, much of the focus of contract organisations is now on assisting companies with drug development, hence the commonly used moniker CRO, or contract research organisation. The role of the CRO isn’t always monolithic however, and whether pharmaceutical companies opt for a full-service approach with their clinical trials, or cherry pick competencies to integrate within their own trial workfl ow, will depend on a variety of factors. Oladimeji Ewumi discusses what these are with Dave Latshaw II, co- founder and CEO of BioPhy, Penelope Przekop, CEO of PDC Pharma Strategy, and Mary Jo Lamberti, research associate professor at Tufts Center for the Study of Drug Development at Tufts University.
D
rug development is unique from other mainstream production processes. It involves extensive research, preclinical testing and clinical trials conducted under rigorous regulatory scrutiny. For some companies, the means to conduct research in-house is simply not financially viable, but even for those who do have the capabilities, the comparably low cost of outsourcing can be an attractive option. As such, it’s common for pharmaceutical and biotechnology companies to
farm out specific or entire aspects of their research and development process to CROs. This allows sponsors to focus on other core competencies, such as drug discovery and marketing. On the other end, CROs help the pharmaceutical industry navigate the ever-evolving landscape of clinical research and drug development – including the various moving parts of clinical trials – by providing specialised expertise in the use of resources, data capabilities, global reach and efficiency.
Clinical Trials Insight /
www.worldpharmaceuticals.net
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